Have a look at our latest update of German price negotiations for drugs that went through the AMNOG benefit assessment. The mean price decrease after negotiations was 28 % for all analysed products, 23 % for orphan drugs and 30 % for non-orphan drugs. If you have any further questions or suggestions, please feel free
The German cabinet, the coalition group of ministers, has decided to introduce the draft bill on the financial stabilization of the statutory health insurance (GKV-FinStG) into the parliamentary process [GKV-Finanzstabilisierungsgesetz - Bundesgesundheitsministerium]. The subjects of the draft bill are amendments to the Social Code Book V, in particular sections § 35a and § 130b, which
Recently, the German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-FinStG). In the following figure, we have summarized the newly proposed negotiation terms. The draft law intends for a stricter regulation of price negotiations following benefit assessments depending on the status of the most
The German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-FinStG). The subjects of the draft are amendments to the Social Code Book V, in particular Articles § 35 a and § 130 b, which include the early benefit assessment of new active substances and
EUnetHTA21 offers early dialogue Joint Scientific Consultations (JSC) in parallel to the EMA scientific advice for medicinal products which are to undergo the EU Joint Clinical Assessments starting in 2025. In 2022, five JCS slots are available. Health technology developers can apply for a JCS during the open call from June 6 to August 31,
The first medicinal products used to treat oncologic diseases and ATMPs will be assessed within the framework of the Joint Clinical Assessments on the level of the European Union (EU) starting in 2025. Until then, the necessary health technology assessment (HTA) process needs to be defined and refined. Today, we were honored to present our
The Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) and amending Directive 2011/24/EU is effective starting today, 11 January 2022. Click for more information>>> The Regulation aims to establish joint clinical assessments of health technologies in the European Union (EU) starting with oncologic
On Dec 13th, 2021, the Regulation on Health Technology Assessment (HTA) has officially been adopted. The new Regulation aims to establish a system for joint clinical assessments of health technologies in the European Union. First assessments of oncologic drugs and ATMPs start in 2025, followed by orphan drugs three years later in 2028 and medicinal
Der Europäische Rat hat in diesem Monat die Verordnung über die EU-weite Bewertung von Gesundheitstechnologien (EU-HTA) angenommen. Gleichzeitig findet aktuell die erste Ausschreibung über eine wissenschaftliche Beratung im Rahmen des EUnetHTA statt. In der offenen Ausschreibung des EUnetHTA 21 JSC-Sekretariats können sich pharmazeutische Unternehmer auf parallele Konsultationen mit der EUnetHTA 21 und der European Medicines
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